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Detection of Schistosomiasis CAA in Travellers After High-risk Water Contact

NCT ID: NCT02194712

Last Updated: 2020-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2019-09-30

Brief Summary

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Schistosomiasis is increasingly encountered among travellers returning from the tropics and is known for its focal endemicity, associated with the presence of the snail intermediate host in fresh water. Because schistosomiasis in travellers is often atypical or asymptomatic due to the low intensity of infection, many infections likely go undiagnosed and will develop into chronic schistosomiasis. Conventional treatment of schistosomiasis in travellers with praziquantel 40mg/kg daily dose is known for its modest success rate. Diagnosis of schistosomiasis relies on egg detection, which has a poor sensitivity in low burden infections, or serology, which is inadequate to monitor cure. The department of parasitology of the Leiden University Medical Center has developed a novel diagnostic test based on the up-converting phosphor technology (UCP) to detect circulating anodic antigen (CAA). This test can be performed on serum and urine to detect low intensity schistosomiasis infections and confirm cure after praziquantel treatment. This study will assess the performance of UCP-CAA in travellers with high-risk water contact.

Detailed Description

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Conditions

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Schistosomiasis

Keywords

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circulating anodic antigen

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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travellers

travellers with recent (\<12 weeks) high risk water contact are included in the study and asked to provide samples for CAA testing

Urine CAA detection

Intervention Type OTHER

In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.

Interventions

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Urine CAA detection

In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Any self-reported high risk water contact, including wading, showering, surfing, walking along wet shore bare-footed or washing with water from a high-risk source, within 12 weeks prior to reporting to the outpatient department
2. Agreement to perform routine diagnostic procedures to diagnose schistosomiasis infection
3. Willing to provide a maximum of three additional blood samples in addition to routine diagnostic procedures
4. Able to provide informed consent

Exclusion Criteria

1. Previous treatment for schistosomiasis
2. Known positive schistosomiasis serology
3. The use of immunosuppressive or immunomodulatory drugs at presentation that compromise the interpretation of schistosomiasis serology
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Meta Roestenberg

OTHER

Sponsor Role lead

Responsible Party

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Meta Roestenberg

M.Roestenberg, MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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M.P. Grobusch, Prof. MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

P.J.J. van Genderen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Harbour Hospital Rotterdam

M. Roestenberg, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Center

Locations

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Academic Medical Center

Amsterdam, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Harbour Hospital

Rotterdam, , Netherlands

Site Status

Countries

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Netherlands

References

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Casacuberta-Partal M, Janse JJ, van Schuijlenburg R, de Vries JJC, Erkens MAA, Suijk K, van Aalst M, Maas JJ, Grobusch MP, van Genderen PJJ, de Dood C, Corstjens PLAM, van Dam GJ, van Lieshout L, Roestenberg M. Antigen-based diagnosis of Schistosoma infection in travellers: a prospective study. J Travel Med. 2020 Jul 14;27(4):taaa055. doi: 10.1093/jtm/taaa055.

Reference Type RESULT
PMID: 32307517 (View on PubMed)

Other Identifiers

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CAA48780

Identifier Type: -

Identifier Source: org_study_id